EU backs J&J's TB drug, postpones decision on Teva MS pill

Reuters Staff

2 Min Read

LONDON (Reuters) - European regulators on Friday recommended approval of an innovative tuberculosis drug from Johnson & Johnson but postponed a keenly awaited decision on a new multiple sclerosis pill from Teva Pharmaceutical Industries.

The European Medicine Agency (EMA) said J&J’s Sirturo, which was approved in the United States last December, had been endorsed as a treatment for multidrug-resistant tuberculosis.

The EMA had also been expected to decide this week on Teva’s laquinimod, which the Israeli company is developing for multiple sclerosis with Swedish partner Active Biotech - but, in the event, this verdict was put off.

Active Biotech said it now expected the decision to come in January.

An EMA spokeswoman declined to give further details on the product but said the agency’s experts could decide to postpone adoption of an opinion if deemed necessary, even when a drug was slated for a decision at a particular meeting.

Prospects for laquinimod are viewed by analysts as uncertain, since the drug missed its main goal in a late-stage trial in 2011 and U.S. regulators have asked for another Phase III study before considering it.

Despite that setback, Teva is still hoping to launch the drug in Europe in 2014. If it makes it, laquinimod will be entering an increasingly crowded marketplace, with rival oral treatments for multiple sclerosis already approved from Novartis, Biogen Idec and Sanofi.

Recommendations for marketing approval by the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) are normally endorsed by the European Commission within a couple of months.